Deborah Pinchev

UK Medical Device Brexit Implications

Medical Device Brexit ImplicationsOn June 26, 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released the Government response to consultation on the future regulation of medical devices in the United Kingdom. This response will effectively guide the UK’s post-Brexit implementation plan for medical device regulation. The following are high-level key points that are sure to be of interest to medical device manufacturers.

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Raje Devanathan

Digital Health Technology (DHT) for Clinical Investigations – FDA Draft Guidance Analysis

 FDA DHT Clinical Investigations Smart phones build a digital profile by tracking and monitoring our behavior and activities. Digitalization is happening all around us and COVID-19 has brought even more digital technologies into our lives. It is encouraging to see how data is being integrated into health care systems.
The FDA thinks we can use these kinds of data for better and safer medical devices. They have built a set of rules around what and how that data can be generated and used.This blog examines their draft guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. You should also read our previous blog on the future of DHT.

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Maria Gonzalez

Quality Management System Regulation (QMSR) Alignment with ISO 13485:2016

QMSR ISO 13485:2016 AlignmentMany organizations have struggled to comply with ISO 13485 and FDA regulations because the FDA did not formally recognize the ISO 13485 standard in their regulations. Now, the FDA is taking a step forward to incorporate ISO 13485 into their Part 820. This will potentially reduce the confusion manufacturers have experienced in the past.
The FDA aims to accomplish this via a proposed rule in which manufacturers are allowed to create a robust Quality Management System (QMS) that complies with a single set of requirements. It also increases international collaboration between the FDA and major markets (Europe, Canada, Australia, Japan, etc.) by minimizing the country specific requirements needed to comply with the Federal Food, Drug and Cosmetic Act (FD&C Act).

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Helen Simons

5 Tips for medical device cyber security

Medical Device Cyber SecurityEditor’s note: This is the 2022 update to the August 2015 “5 Tips for medical device cyber security” blog by Vincent Crabtree. Read the original one here.
In this modern world, cyber security and data protection has become a familiar topic to us all. From agreeing to cookies on website, to data privacy agreements to sign, to ever increasing log ins and access controls, we all feel the impact of cybersecurity protections.
They may seem burdensome to the user but they are there for a reason. As devices and websites collect more and more data about us and our habits, this data becomes valuable to those wishing to exploit it. Cyber security attacks and data privacy breaches are a relatively common occurrence these days.

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Doug Bailey

How to Create a Useful Medical Device Project Plan

Medical Device Project PlanI could spend a lot of time trying to make sure my medical device project plan is useful. But most effective proof for me is hearing this phrase: “Hey Doug, I was looking at the plan…”.
Let’s count the wins in that phrase: 1) Someone thought about accessing the plan. AKA, they saw value in the plan. 2) Someone could access the plan. 3) Someone could navigate the plan to get the information they were seeking.

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T. David Pyron

Risk Management for Medical Device Projects

Device Development Risk ManagementMy goal as a medical device development program manager is to save time while managing risk. I save time by reinforcing a concept you likely apply every day, but might not use in your medical device development project.
In my experience, dealing with the fires of the day always take precedent over managing things that might not happen in the future. (spoiler alert: those fires might have been prevented by project-managing the things that haven’t happened yet).

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Julian Grove

High Level Program Planning: A Journey, Not the Destination

Developing innovative and life-changing products provides a wellspring of inspiration as our “destinations.” But “anything worth doing is never easy” and this is a pretty accurate capture of medical device product development. If we are going to spend most of our time on the journey, wouldn’t it be a whole lot more enjoyable if we have trust in and feel comfortable with our travel companions?
The reality is that when we invest in our relationships and appreciate the journey, we are much more likely to reach our goals. Ironically, focusing too much and rushing towards the destination may be the single biggest obstacle to getting there.

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Arash Samimi

Creativity, Collaborations and Culture from the Lens of a Systems Engineer

Medical Device Systems Engineer Creative CollaborationsI have learned the most important lesson about innovation through my role as a medical device systems engineer: invention and adoption of new ideas is only possible through coherent and feedback driven collaborations. Indeed, building a new product is more than the product. It is about creative teams working together and navigating ambiguity in relentless pursuit of a shared goal. Within this context, systems engineering exists to enable creativity and nurture a collaborative culture by focusing on the bigger picture.

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Kashif Siddiqui

4 Hidden Medical Device Development Costs

Hidden Costs Medical Device DevelopmentUnnecessary repeated effort is an insidious source of hidden costs. In medical device development, an iterative work process is fundamental to creating a successful product, but if the iterative process is not performed with careful consideration, it can become the source of a lot of hidden costs.
Transitioning from one team to another, distributing work, or passing the baton typically involves some overlap in tasks and activities performed. Even within a single team, repeated work or practices could be optimized.

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Ryan Field

Medical Device Camera Image Sensor Considerations

Medical Device Camera SensorProduce the most high-fidelity images and/or cleanest data possible

Part 3: Types of Image Sensors

Camera sensors are common components of medical devices. This blog covers various types of image sensors. Generally, image sensors consist of an array of photosensitive pixels. In typical camera applications, such sensors measure the spatial pattern of light focused by a lens (i.e., an image). In some applications (for example, digital holography or shadow imaging), image sensors may be used without a lens.

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Alex Gunson

When Tolerance Studies Add Value in Medical Device Development

Device Design Tolerance Studies Coming from a high volume and high precision electronics manufacturing background, I lived in a world where every design required a tolerance study. Entering the low volume world of biomedical entrepreneurship, I’ve been surprised by clients telling me that tolerance studies are too expensive and that they are happy to proceed without them. This led me to consider when a tolerance study actually adds value to a medical device design.

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